NeuRx Electrode Delivery Instrument Instruction Manual Rev C

TABLE OF CONTENTS INTENDED USE

2

SYMBOL DESCRIPTIONS

3

DEVICE DESCRIPTION

4

STERILIZATION

5

INSTRUMENT DISASSEMBLY FOR CLEANING

6

STEP 1: REMOVE NEEDLE PIVOT STEP 2: DISCONNECT

1

6

INTENDED USE The NeuRx Diaphragm Pacing System™ (NeuRx DPS™) provides ventilatory support in patients with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury, central hypoventilation, amyotrophic lateral sclerosis, and other injuries or diseases affecting the neuromuscular respiratory pathways.

2

SYMBOL DESCRIPTIONS The Warning symbol precedes warning information that mitigates a risk that is not obvious to the operator. Indicates that a potentially hazardous situation which, if not avoided, could result in harm to the operator or patient.

Y

The Caution symbol appears next to precautionary information when the intention is solely to inform. Indicates that a potentially hazardous situation which, if not avoided, may result in minor or moderate personal injury or property damage. This word is used to also alert against unsafe practices.

M

The Manufacturer symbol appears next to the manufacturer’s name and address.

h The Reference symbol appears preceding the part number for the device. The part number is a unique numeric identifier for the device.

g The Lot symbol appears preceding the lot number for a device. Devices manufactured at the same time using identical material and parts will share a common lot number.

f The Serial Number symbol appears on devices that require unique identification.

N

The Manufactured Date symbol appears on devices as an indication of the date of manufacture. The date is expressed as the year and month.

p

The Keep Dry symbol appears on all packages of devices requiring to protect the packaging from potential damage.

L

The Don’t Use If Packing Damaged symbol appears on all packages of devices requiring to dispose of the device if the packaging has suffered damage.

i The Accompanying Documents symbol appears on all packages of devices indicating that instructions for use are available for additional information. C0086 The Regulatory Marking of Conformity symbol indicates that the device meets

Medical Device Directive 93/42/EEC. This has been certified by notified body number 0086.

P The European Community Representative symbol indicates the identification of the authorized representative for the distribution of devices into the European community.

3

DEVICE DESCRIPTION The NeuRx Diaphragm Pacing System™ is a system designed to help patients breathe by stimulation of their diaphragm muscles. It is implanted using standard laparoscopic surgical techniques in an outpatient procedure. An intramuscular electrode is introduced into the abdominal cavity with the electrode delivery instrument (REF 22-0018).

4

STERILIZATION The device is sterilized using steam and is for single use only. Reprocessing and resterilization of this device is required. Failure to properly reprocess and resterilize the device may create the risk of contamination and patient infection.

Place the assembled device into appropriate individual sterilization containers such as self-sealable autoclavable pouches. The device must be double-pouched with proper labeling attached to outer packaging layer. Sterilize using in-house sterilization procedures that meet AAMI TIR12-2004 parameters for dynamic-air-removal steam sterilization cycles. A minimum full steam cycle of 4 minutes pre-vacuum at 132°C is required.

The device may be resterilized, according to the sterilization process, a maximum of forty times. Continued resterilization of the device beyond this limit may result in patient harm. Do not use the device if the sterile package is open or damaged. Use of the device from an opened or damaged sterile package may result in patient harm.

5

INSTRUMENT DISASSEMBLY FOR CLEANING STEP 1: REMOVE NEEDLE PIVOT

YELECTRODE INSERTION NEEDLE IS VERY SHARP!!!

6

DISASSEMBLY STEP 1: REMOVE NEEDLE PIVOT (CONTINUED)

7

DISASSEMBLY STEP 2: DISCONNECT EXTENSION TUBE

Y Before starting this step, make sure the trigger stop is disengaged and the trigger handle is in the extended position.

TRIGGER STOP

EXTENSION TUBE

TUBE ATTACHMENT NUT

LOOSEN & SLIDE BACK TUBE ATTACHMENT NUT 8

DISASSEMBLY STEP 2: DISCONNECT EXTENSION TUBE (CONTINUED)

BACK TUBE AWAY FROM CYLINDER FACE

DIS-ENGAGE GEAR RACK ROD

9

DISASSEMBLY STEP 2: DISCONNECT EXTENSION TUBE (CONTINUED)

SLIDE EXTENSION TUBE AWAY FROM CYLINDER. (ELECTRODE TUBE SLIDES OUT OF BORE IN ACTUATOR)

(ELECTRODE TUBE)

10

DISASSEMBLY STEP 3: REMOVE GEAR RACK ROD FROM TUBE GEAR RACK ROD NORMALLY POSITIONED IN THIS BORE, AS SHOWN.

PULL GEAR RACK ROD OUT OF TUBE ASSEMBLY

11

DISASSEMBLY STEP 3: REMOVE GEAR RACK ROD FROM TUBE (CONTINUED)

GEAR RACK ROD

TUBE ASSEMBLY `

12

DISASSEMBLY STEP 4: HANDLE DISASSEMBLY PIVOT SHOULDER SCREW ACTUATOR SHOULDER SCREW

SPRING

ACTUATOR PISTON

TRIGGER HANDLE

LOOSEN BOTH SHOULDER SCREWS (NOTE: THE TWO SCREWS ARE IDENTICAL)

13

DISASSEMBLY STEP 4: HANDLE DISASSEMBLY (CONTINUED) REMOVE ACTUATOR SHOULDER SCREW.

Y

HOLD FINGER ON

END OF ACTUATOR TO PREVENT ACTUATOR AND SPRING FROM FALLING OUT.

SPRING ACTUATOR PISTON

14

DISASSEMBLY STEP 4: HANDLE DISASSEMBLY (CONTINUED) REMOVE PIVOT SHOULDER SCREW

REMOVE TRIGGER HANDLE

15

DISASSEMBLY STEP 4: HANDLE DISASSEMBLY (CONTINUED)

16

PARTS ARE NOW READY FOR CLEANING Automated method of cleaning may be used only after the stated manual cleaning procedure has been completed. After each use, the needle/pivot-wheel assembly and pivot wheel screw should be disposed of in appropriate sharps container and the instrument should be disassembled prior to cleaning. All parts should be cleaned within 2 hours to prevent fluid and debris from drying. Wear gloves and eye protection during the cleaning procedure. Place all parts in a container. - Prepare a cleaning solution using an enzymatic detergent presoak-pluscleanser, such as ENZOL™ or Cidezyme™. Prepare the solution according to manufacturers’ recommendations. - Place the parts in a container and prepare enough solution to completely cover all of the parts. The use of harsh or abrasive cleaning agents, such as chlorine bleach, is not recommended as it may affect the integrity of the surgical device, or may cause pitting or other forms of corrosion. - Allow parts to soak in solution for 10 minutes. After this time, use a soft bristled brush and gently clean the exterior of the parts, paying attention to crevices and especially the needle pivot and gear rack rod until all visible soil has been removed. - Visually inspect the parts to ensure the removal of soil. - Flush the interior of the inner lumen of the electrode tube and gear rack exit hole located in the tip of the device. - Use a soft bristled brush to clean the inner lumen of the tube assembly before proceeding. - After soaking/washing, remove the parts from the cleaning solution and rinse with deionized water for 3 minutes. -

Visually inspect each part for cleanliness and re-clean if necessary.

17

INSTRUMENT ASSEMBLY FOR USE STEP 1: HANDLE ASSEMBLY

18

ASSEMBLY STEP 1: HANDLE ASSEMBLY (CONTINUED)

INSTALL TOP SCREW ONLY FOR THIS STEP (THE TWO SCREWS ARE THE SAME AND CAN BE USED IN EITHER POSITION)

19